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Monitor sleep, mood, and substance use for Delayed Sleep Phase Syndrome

N/A

Recruiting

Led By Brant Hasler, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physically and psychiatrically healthy

Be younger than 18 years old

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upcontinuously up to every 6 months for up to 5 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.

Eligible Conditions

Delayed Sleep Phase Syndrome

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You are in good physical and mental health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously up to every 6 months for up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuously up to every 6 months for up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously up to every 6 months for up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Circadian alignment at 2 weeks

Change from baseline in Sleep timing at 2 weeks

Change from baseline in behavioral inhibition at 2 weeks

+4 more

Secondary outcome measures

Caffeine use

Substance use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Advance/Extend ManipulationExperimental Treatment4 Interventions

For ~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to: Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration) Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed) Increase morning bright light exposure via bright light goggles (30 min after rise) Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph

Group II: ControlActive Control1 Intervention

Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,674 Previous Clinical Trials

16,301,858 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,368 Previous Clinical Trials

2,049,016 Total Patients Enrolled

Brant Hasler, PhDPrincipal Investigator - University of Pittsburgh

University of Pittsburgh

Media Library

Monitor sleep, mood, and substance use Clinical Trial Eligibility Overview. Trial Name: NCT04792697 — N/A

Delayed Sleep Phase Syndrome Research Study Groups: Control, Advance/Extend Manipulation

Delayed Sleep Phase Syndrome Clinical Trial 2023: Monitor sleep, mood, and substance use Highlights & Side Effects. Trial Name: NCT04792697 — N/A

Monitor sleep, mood, and substance use 2023 Treatment Timeline for Medical Study. Trial Name: NCT04792697 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the capacity to partake in this trial?

"This clinical trial is recruiting 100 adolescents between the ages of 13 and 15 with delayed sleep phase syndrome. Those hoping to be admitted must meet a set of criteria, such as being enrolled in traditional high-school learning (excluding cyber or home schooling; although school closures due to COVID are an exception), demonstrate good physical and mental health, provide written consent/assent from guardians if applicable, and have bedtimes after 11:15PM for those assigned to the experimental protocol."

Answered by AI

How many individuals are currently participating in this clinical trial?

"That is correct. According to the data hosted on clinicaltrials.gov, this medical trial first appeared on May 1st 2021 and was recently updated as of August 1st 2022. It requires 100 individuals from a single location."

Answered by AI

Is the eligibility criteria of this clinical trial inclusive to individuals over 65 years old?

"This clinical study is open to participants between the ages of 13 and 15."

Answered by AI

Is this analysis currently open to recruitment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical experiment is currently recruiting patients; it was originally posted on May 1st 2021 and last updated on August 1st 2022. The study necessitates 100 volunteers from a single site for participation."

Answered by AI